The Hancock pericardial xenograft: incidence of early mechanical failures at a medium-term follow-up

The Hancock pericardial xenograft has been used in our Institution since August 1981 as an alternative to porcine bioprostheses. Up to July 1984, 97 Hancock pericardial xenografts have been implanted in 84 patients; of 76 operative survivors with a mean age of 55.2±13 years (range 13–75 years), 50 had undergone aortic valve replacement, 16 mitral valve replacement and 10 mitral-aortic valve replacement. Follow-up ranged from 0.5 to 5.2 years with a cumulative duration of 239 patient/years and is 99% complete. Actuarial survival is 92%±4% for patients with aortic valve replacement and 84%±10% for patients with mitral valve replacement at 5 years, and 77%±14% for those with mitral-aortic valve replacement at 4 years. Thromboembolic episodes occurred in 2 patients (1 after aortic and 1 after mitral valve replacement). The actuarial freedom from emboli is 100% for patients with mitral-aortic valve replacement at 4 years, and 96%±3% for patients with aortic and 93%±6% for patients with mitral valve replacement at 5 years. Reoperation was performed in 13 patients (9 aortic, 2 mitral and 2 mitral-aortic valve replacements), because of endocarditis in 3 (2 aortic and 1 mitral valve replacement), paravalvular leak in 1 (aortic valve replacement), and primary tissue failure in 9 (6 aortic, 1 mitral and 2 mitral-aortic valve replacements). Actuarial freedom from primary tissue failure is 72%±9% for aortic and 83%±8% for mitral Hancock pericardial xenografts at 5 years. Eleven xenografts explanted because of primary tissue failure were studied pathologically. All showed commissural tears with gross regurgitation; calcium deposits were severe in 2, mild but unrelated to the tears in 2 and absent in 7. Collagen disarray was observed at the site of cusp rupture while the collagen was well preserved in the intact areas of the leaflets. Our results show that: 1) Hancock pericardial xenografts have a high rate of early primary tissue failure, 2) primary tissue failure is caused by cusp rupture at the commissures and can be considered fatigue-induced, 3) tissue calcification does not influence the durability of pericardial xenografts which do not represent a valid alternative to porcine bioprostheses.     

Hancock II bioprosthesis: a glance at the microscope in mid-long-term explants

BACKGROUND AND OBJECTIVES: The Hancock II bioprosthesis is a second-generation porcine valve xenograft treated with the detergent sodium dodecyl sulphate (T6) to retard calcification. The aim of this investigation was to study the gross and microscopic features in Hancock II explants to assess the structural changes occurring with time. METHODS: Among 1382 Hancock II bioprostheses (701 isolated aortic, 421 isolated mitral, 130 double) implanted from 1983 to 1997 in 1252 patients, 22 (16 mitral, 6 aortic) were removed at reoperation until 1999 and were available for pathological investigation: infective endocarditis occurred in 5 and structural deterioration in 8, whereas in the remaining 9 xenografts reoperation was performed for nonstructural valve deterioration (paravalvular leak in 4 and prophylactic replacement in 5). Morphological investigation consisted of gross examination and x-ray, histologic, immunohistochemistry, electron microscopic, and atomic absorption spectroscopic examination. RESULTS: The cause of structural valve deterioration was dystrophic calcification in 4 cases (1 aortic, 3 mitral; range of time graft was in place, 101 to 144 months), non-calcium-related tears in 3 cases (all mitral, range 121 to 163 months), and commissural dehiscence in 1 (aortic, range 156 months). Five of the nonstructural valve deterioration explants (range 42 to 122 months) showed only pinpoint mineralization at the commissures. Mean calcium content in nonstructural deterioration explants was 14.70 +/- 22.33 versus 99.11 +/- 81.52 mg/g in explants with structural valve deterioration. Electron microscopic examination showed early nuclei of mineralization mostly consisting of calcospherulae upon cell debris. Local or diffuse lipid insudation was observed in all but 2 explants and consisted of cholesterol clefts, lipid droplets, and lipid-laden macrophages featuring foam cells. The lipid insudation was the most plausible cause of tearing in 2 explants. CONCLUSIONS: These pathologic findings support the clinical results of a delayed occurrence of structural failure of Hancock II bioprostheses and a mitigation of mineralization by the anti-calcification treatment. However, other factors such as lipid insudation may come into play in the long term.     

Aortic valve replacement with stentless porcine aortic bioprosthesis

Twenty-nine patients were entered in a clinical trial on aortic valve replacement with a stentless glutaraldehyde-fixed porcine aortic valve. This bioprosthesis is secured to the aortic root by the same technique used for aortic valve replacement with aortic valve homografts. The functional results obtained from this operation have been most satisfactory. To assess the hemodynamic benefit of eliminating the stent of a porcine aortic valve, we matched 22 patients with a stentless porcine bioprosthesis for age, sex, body surface area, valve lesion, and bioprosthesis size to 22 patients who had aortic valve replacement with a Hancock II bioprosthesis. Mean and peak systolic gradients across the aortic bioprosthesis and effective aortic valve areas were obtained by Doppler studies. Gradients across the stentless bioprosthesis were significantly lower than gradients across the Hancock II valve for every bioprosthesis size. Effective aortic valve areas of the stentless bioprosthesis were significantly larger than the valve areas of the Hancock II valve. Our data demonstrate that the hemodynamic characteristics of a glutaraldehyde-fixed porcine aortic bioprosthesis are greatly improved when the aortic root is used as a stent for the valve. This technique of implantation is expected to enhance the durability of the bioprosthesis, because the aortic root may dampen the mechanical stress to which the leaflets are subjected during the cardiac cycle.     

Calcification characteristics of porcine stentless valves in juvenile sheep.

OBJECTIVE: To compare calcification characteristics of two porcine stentless valves (Toronto SPV and Freestyle) with different designs, fixation and antimineralization techniques using a juvenile sheep model of valve implantation inside the circulation. METHODS: The stentless valves (n = 2 x 6) were implanted in juvenile sheep in the pulmonary artery as an interposition, while the circulation was maintained with a right ventricular assist device. The model was validated by the implantation of, clinically well-known, porcine (Hancock II) and pericardial (Pericarbon) valves. Half of the valves were explanted after 3 months, the rest after 6 months. Valves were examined macroscopically, by X-ray, light microscopy (HE, Masson, Von Giesson, Von Kossa, PTAH stains), and transmission electron microscopy. Quantitative determination of the calcium content of the cusps was performed with atomic absorption spectrometry. RESULTS: After 3 months, the Freestyle had an extensively calcified aortic wall, most prominent at the outflow side of the porcine valve. After 6 months, calcification increased transmurally, but the valve cusps were free of calcification, and the inflow side was only slightly calcified. The Toronto SPV valve also started to calcify at the inflow side of the valve after 3 months with increased calcification after 6 months. The base of the Toronto SPV valve cusps showed slight calcification after 6 months of implantation. CONCLUSIONS: The pattern of calcification of the porcine aortic wall differs between the two studied stentless valves, with calcification located predominantly at the outflow side in the Freestyle valve, but also at the inflow side in the Toronto SPV valve. The cusps of the Freestyle valve were less prone to calcification than those from the Toronto SPV valve.     

Aortic valve/root replacement using a stentless bioprosthesis (Medtronic Freestyle valve)

BACKGROUND: The purpose of the study is to assess the clinical and hemodynamic performance of aortic valve replacement (AVR) with the Freestyle bioprosthesis. METHODS: Twenty-one patients received AVR with a Freestyle aortic root bio-prosthesis between May 1998 and October 1999. Eighteen patients underwent AVR with subcoronary method and three patients with aortic root (full root) method. Patients were evaluated postoperatively at discharge by clinical examination and color Doppler echocardiography. RESULTS: There was one death due to multi-organ failure. No patients experienced valve deterioration, paravalvular leak, unacceptable hemodynamic performance, nor thromboembolic event. Excellent function is demonstrated by very low gradient (mean gradient 7.2 +/- 4.7 mmHg) through aortic valve and no significant aortic regurgitation (none: 11, trivial/mild: 10). All patients had been in New York Heart Association Functional Class III and IV preoperatively, and after surgery, 17 patients were in Class I, and 3 were in Class II. CONCLUSION: The Freestyle bioprosthesis has good clinical and hemodynamic performance without Coumadin. Further follow-up is required to evaluated valve durability.     

Early mechanical failures of the Hancock pericardial xenograft

From August 1981 to July 1984, a total of 97 Hancock pericardial xenografts were implanted in 84 patients, whose ages ranged from 13 to 75 years (mean 55.7 +/- 13). Mitral value replacement was performed in 17, aortic valve replacement in 54, and mitral-aortic valve replacement in 13. Operative survivors were reevaluated from July to September 1985. Cumulative duration of follow-up is 167 patient-years (range 0.5 to 4.1 years), and follow-up is 99% complete. The overall late mortality (at 4 years) is 3.6% +/- 1.4% per patient year, and the actuarial survival rate is 95.4% +/- 3% for aortic valve replacement, 74.7% +/- 16.5% for mitral valve replacement, and 67.1% +/- 20.7% for mitral-aortic valve replacement. One patient sustained a thromboembolic event after mitral valve replacement, but no such complications occurred after aortic or mitral-aortic valve replacement. Actuarial freedom from embolism at 4 years is 100% for aortic and mitral-aortic valve replacement and 93.3% +/- 6.4% for mitral valve replacement. Reoperation for Hancock pericardial xenograft dysfunction was performed in seven patients (five aortic and two mitral-aortic). In the aortic valve replacement group the causes were endocarditis in one, paravalvular leak in one, and primary tissue failure in three; all survived reoperation. The two patients with mitral-aortic valve replacement required reoperation because of primary tissue failure of both Hancock pericardial xenografts, and one died. All values explanted because of primary tissue failure showed commissural tears causing severe prosthetic regurgitation. Calcium deposits were severe in one and mild but unrelated to the cusp rupture in another. Collagen disarray was seen only at the site of the tears, whereas the collagen structure was well preserved in the intact parts of the cusps. Four patients with aortic valve replacement and one with mitral valve replacement show evidence of Hancock pericardial xenograft failure and are awaiting reoperation. The actuarial freedom from primary tissue failure at 4 years is 74.3% +/- 9.8% for aortic and 78.9% +/- 13.2% for mitral Hancock pericardial xenografts. At medium-term follow-up, the Hancock pericardial xenograft has shown poor durability and an extremely high rate of early mechanical failure, especially in the aortic position. These observations suggest the need for a close follow-up of Hancock pericardial xenograft recipients and possibly elective reoperation in asymptomatic patients with clinical evidence of prosthetic failure. These results have led us to discontinue the clinical use of this pericardial xenograft.     

St. Jude SPV Versus Medtronic Freestyle: A Single Institution Comparison of Two Stentless Aortic Valves

BACKGROUND: Improved hemodynamics with the SPV and Freestyle bioprostheses compared to stented valves have been reported. It has been suggested that there is more aortic insufficiency (Al) with the Freestyle than with the SPV valve. This study was designed to assess the hemodynamic performance of these two valves implanted at a single institution with all echocardiograms reviewed by one echocardiographer. METHODS: From 1993 to 1997 112 patients underwent aortic valve replacement with stentless aortic valves (69 SPV, 43 Freestyle). There were no major preoperative differences in patient age, gender, NYHA class, or ejection fraction between groups. Echocardiographic assessment was obtained at discharge, 3 to 6 months following surgery, and yearly thereafter. RESULTS: Mean follow-up was 15.9 months for the SPV and 28.6 months for the Freestyle. Both valves have excellent valve areas and low transvalvar mean gradients. There is a trend for more Al in the SPV group. At 1 year, 1+ or greater Al was present in 11 of 42 SPV patients compared to 2 of 34 Freestyle patients (p = 0.030). Al has tended to remain stable over time, has not progressed, and is not clinically evident. DISCUSSION: Differences in the previously reported incidence of aortic insufficiency with these valves may have more to do with the method of reporting Al than its actual frequency. Within our institution, there has been slightly more mild Al with the SPV valve than with Freestyle. Long-term follow-up of these valves is needed to determine if the Al progresses or becomes clinically important. To date there is no such trend with either valve.     

Failure of Hancock xenograft valve: importance of valve position (4- to 9-year follow-up)

To evaluate long-term durability of Hancock valves, we reviewed our results in 107 hospital survivors (120 valves) who were operated on during 1974 through mid-1979. Mitral valve replacement was done in 63 patients, aortic valve replacement in 20, and mitral valve replacement combined with other procedures in 24. The 7-year survival was 84 +/- 4% (standard error of the mean) for 91 patients and 97 valves. During a follow-up of 590 patient-years, 15 (12 mitral and 3 aortic) of 120 valves at risk (87 mitral, 32 aortic, 1 tricuspid) were removed from 14 patients. Six valves (3 mitral and 3 aortic) were removed because of bacterial endocarditis. One mitral valve was removed because of thromboembolism. Eight mitral valves were removed because of valve structural failure, which occurred at a mean follow-up of 42 months. These valves showed extensive calcification, leaflet perforation, or cusp tear. Structural failure was unrelated to valve size, year of implantation, or valve shelf-life. Structural failure was not seen after aortic valve replacement. Results show that structural failure of the Hancock xenograft valve in the mitral position is related primarily to valve position. After aortic valve replacement, valve failure is predominantly due to endocarditis. Although medium-term (mean, 6-year) durability of this xenograft valve compares satisfactorily with prosthetic valves, its high failure rate in the mitral position indicates the necessity for improvement in valve mounting, design, and preservation.     

Late results of heart valve replacement with the Hancock II bioprosthesis

OBJECTIVE: To review the late clinical outcomes of patients who had isolated aortic or mitral valve replacement with the Hancock II bioprosthesis. METHODS: From 1982 to 1994, 670 patients underwent isolated aortic valve replacement and 310 underwent isolated mitral valve replacement with the Hancock II bioprosthesis (Medtronic Inc, Minneapolis, Minn). Mean age was 65 +/- 12 years in both groups. Most patients were in New York Heart Association functional classes III or IV, and concomitant coronary artery disease was present in 44% of patients in the aortic valve group and 41% of patients in the mitral valve group. Patients were followed up prospectively at periodic intervals. Mean follow-up was 87 +/- 45 months in the aortic valve group and 83 +/- 50 months in the mitral valve group, and it was 99% complete. RESULTS: Actuarial survival at 15 years was 47% +/- 3% in the aortic valve group and 30% +/- 5% in the mitral valve group. Older age, advanced functional class, impaired left ventricular function, active endocarditis, and coronary artery disease were independent predictors of late death. The freedom from thromboembolic complications at 15 years was 83% +/- 3% in the aortic and 87% +/- 3% in the mitral valve group. The freedom from infective endocarditis at 15 years was 96% +/- 1% in the aortic and 91% +/- 1% in the mitral valve group. At 15 years, the actuarial and actual freedom from structural valve deterioration was 81% +/- 5% and 90% +/- 3%, respectively, in the aortic group and 66% +/- 6% and 83% +/- 3%, respectively, in the mitral group. Younger age, mitral valve position, and poor ventricular function were independent predictors of structural valve deterioration. The freedom from repeat valve replacement at 15 years was 77% +/- 5% in the aortic group and 69% +/- 6% in the mitral. The vast majority of patients had functional improvement after valve replacement. CONCLUSIONS: The Hancock II bioprosthesis has provided good clinical outcomes and is a durable valve, particularly in the aortic position in older patients.     

When a Mechanical Valve Goes Freestyle: A Patient Tailored Valve-In-Valve Implantation

In case of a redo operation after a full root replacement there are two possible options: replacing the entire root or performing a more conservative valve-in-valve implantation. Regarding the relatively high morbidity and mortality of a redo root replacement, the valve-in-valve implantation is the preferred choice if technically feasible. We present the case of a valve-in-valve implantation with a St. Jude mechanical valve in a Medtronic bioprosthesis in a 57-year old man. Follow-up echocardiography after 1 month showed a mean gradient of 17 mmHg and no paravalvular leakage. The combination of a St. Jude bileaflet mechanical valve implanted in a Freestyle root prosthesis has not been described. This case shows that patient tailored treatment with a St. Jude bileaflet mechanical valve in a Freestyle aortic root valve can be safely performed and might be the preferred choice for younger patients, if technically feasible.     

Medtronic Freestyle Aortic Root Bioprosthesis: Implant Techniques

BACKGROUND: The Medtronic Freestyle aortic root bioprosthesis is a complete porcine aortic root to allow implantation (1) as a subcoronary valve replacement by removing graft sinus aorta, (2) as a cylinder with the sinotubular junction intact within the aorta (root inclusion), or (3) as a complete aortic root replacement. The choice among the three implant techniques depends on surgeon preference or upon the pathology encountered. The advantages and differences among the three implant techniques are examined. METHODS: The Medtronic Freestyle bioprosthesis was implanted in 1163 patients in a Food and Drug administration (FDA) clinical trial between August 1992 and October 1997. There were 21 centers in the international trial using a single data repository. Clinical data was collected prior to and at operation, at 3 to 6 months and annually. The data were compiled and statistical analysis performed at the data center. RESULTS: Patients having subcoronary valve implants were older (80% > 65 years) and aortic occlusion time was about 20 minutes less than the other methods. Patients having aortic root replacement presented with more aortic valve insufficiency (20%). Pathology of the aortic root and ascending aorta requiring repair was 26%, and larger (27 mm) valves were used in 40% of patients. Risk of operation was lowest (5.0%) with subcoronary valve implants and highest (11.7%) with root replacement technique. Thromboembolism was higher, early and late, with root inclusion (3.0, 3.9%/patient per year) and root replacement (3.2, 3.0%/patient per year) than for subcoronary implants (1.8, 1.6%/patient per year). There were more patients taking warfarin at the 4-year point with root inclusion (20%) or root replacement techniques (24%) than among patients having subcoronary implants (14%). Explants of the valve occurred in 2% of patients, none of whom had aortic root replacement. CONCLUSIONS: The Medtronic Freestyle bioprosthesis is an effective and versatile device for replacement of the aortic valve. It offers implant techniques that can treat the aortic root pathology encountered at surgery and allows the operation to proceed according to surgeon preference.     

Freestyle valve for right ventricular reconstruction in Ross operation; report of a case

A 28-year-old man with active aortic valve endocarditis underwent emergency surgery. Because he had progressive congestive heart failure and uncontrolled infection. Aortic root replacement for Ross procedure was required because of complete debridment of infective tissue. His operation were performed under extracorporeal circulation and moderate hypothermia, the operation procedure was following, (1) taking off auto-pulmonary artery valve, (2) removing dysfunctional aortic valve and auto-transplantation of pulmonary valve on aortic root, (3) putting a pulmonary Freestyle Aortic Valve to rebuild right ventricular outflow tract. Follow-up showed heart function was in class I (New York Heart Association) , aortic and pulmonary valve function was very well. Streptococcus milleri group was isolated from his blood and infectious aortic valve postoperatively. We believed that a Ross operation with Freestyle Aortic Valve is more resistant to infection, therefore, it might be an option for infective endocarditis with aortic valve endocarditis.     

Reoperation due to failure of a Freestyle bioprosthesis

We report re-do aortic valve and ascending aorta replacements by using the valve-on-valve technique for primary tissue failure of a Freestyle bioprosthesis. A 74-year-old male, who had had a 25 mm Freestyle bioprosthetic valve implanted by the sub-coronary method 5 years previously for aortic valve regurgitation due to congenital bicuspid valve, was referred to our hospital for dyspnea and palpitation. He presented with heart failure secondary to aortic regurgitation due to primary tissue failure, and computed tomography demonstrated an enlarged ascending aorta (5 cm in diameter). The operative findings revealed that the Freestyle bioprosthetic valve had a leaflet tear at the left coronary cusp. We replaced the degenerated Freestyle bioprosthesis with a 19 mm Mosaic aortic bioprosthesis by using the valve-on-valve technique, and ascending aorta replacement was performed simultaneously. This technique can be useful for re-do surgery for degenerated stentless valves to avoid potential risks of complete excision of the bioprosthesis.     

Aortic valve replacement with medtronic freestyle bioprosthesis: operative technique and results

OBJECTIVE: This study evaluates the initial results for safety and efficacy of aortic valve replacement (AVR) using the Medtronic Freestyle Bioprosthesis. METHODS: One hundred three patients underwent AVR with the Medtronic Freestyle Bioprosthesis over a 40-month period. There were 59 male and 44 female patients with a mean age of 74 years (range 36 to 88 years). Valve size ranged from 19 to 27 mm, and all valves were implanted using a freehand subcoronary technique. Anticoagulation with coumadin was only used for atrial fibrillation. Aspirin was given to patients with associated coronary artery disease. Echocardiography to assess transvalvular pressure gradient and effective valve orifice area was performed at discharge, 3 to 6 months, 1 year, and then annually. RESULTS: There were 4 (3.9%) deaths within 30 days of operation and 5 (4.9%) late deaths. Two (1.9%) deaths were valve-related, one from commissural dehiscence and one from bacterial endocarditis. Three (2.9%) deaths, two early and one late, were from other cardiac causes. The remaining deaths were from noncardiac causes. Five (4.9%) patients suffered a thromboembolic event, two had permanent neurological deficits, two had transient neurological events, and one had coronary artery occlusion. Mean transvalvular gradient assessed by echocardiography was low at all time intervals: discharge (12.8 mmHg), 3 to 6 months (11.3 mmHg), 1 year (12.0 mmHg), and 2 years (11.6 mmHg). Mean effective valve orifice area was good at all time intervals: discharge (1.4 cm2), 3 to 6 months (1.5 cm2), 1 year (1.6 cm2), and 2 years (1.6 cm2). Of the 38 patients assessed by echocardiography at 1 year, 33 (87%) had no or trivial valve incompetence and the remainder had mild valve incompetence. CONCLUSIONS: Aortic valve replacement with the Medtronic Freestyle Bioprosthesis has a low incidence of early valve-related mortality and thromboembolism. The bioprosthesis demonstrates good hemodynamic performance even in small diameters and is particularly well suited for older patients and the small aortic root.     

Initial Clinical Experience with the Toronto Stentless Porcine ValveTM

We report our initial experience from April 1992 to November 1993 with a stentless porcine valve (Toronto SPV^TM Valve, St. Jude Medical) for aortic valve replacement (AVR) in 21 consecutive patients and compare this group to a matched cohort that underwent AVR with a Hancock II (Medtronic) bloprosthesis. There were no hospital deaths in either group. Postoperative hospitalization was 5.5 ± 0.8 versus 7.0 ± 2.3 days (p = 0.004). Aortic cross-clamp time was 114.5 ± 15.7 min In the SPV group and 96.0 ± 25.0 min in the Hancock II group (p = 0.003). Complications in the SPV group were: one patient suffered perioperative infarction, one patient required late reoperation for left main stenosis, and one patient died suddenly following femoral thrombectomy at another center. Complications in the Hancock II group included: one patient with postoperative low output syndrome, and two late deaths (one from an aortic dissection and the other from chronic liver disease secondary to alcohol abuse). Comparison data indicate that the average size valve implanted in the SPV group was higher than in the Hancock II group (26.3 ± 1.9 vs 24.0 ± 1.9, p = 0.001). In the SPV group, 16 patients had 0 or trivial regurgitation and 1+ regurgitation was seen in 5 patients; regurgitation did not change over a 12-month follow-up. We observed a decrease in gradients over time (p < 0.01). Our results are compatible with a hypothesis that the ventricle undergoes remodeling over time, once the obstruction is relieved. We think the stentiess design is an important feature that allows this to occur. Furthermore, this design allows for the implantation of a larger size valve for the same body size, as well as for decreased shear forces during diastole, with accompanying better hemodynamics, and potential improvement in longevity. These results indicate that the SPV valve has excellent hemodynamic characteristics that do not appear to change over a short follow-up period.     

Aortic valve replacement with the freestyle stentless bioprosthesis with respect to spacial orientation of patient coronary ostia

OBJECTIVE: This study evaluates our results for safety and efficacy of aortic valve replacement using the Freestyle bioprosthesis (Medtronic, Inc, Minneapolis, Minn) with a new modified subcoronary implantation technique. This technique takes into account the spacial orientation of the stentless bioprosthesis in the aortic root with respect to the patient's coronary ostia rather than the native commissures. METHODS: Fifty-two consecutive patients with predominant aortic valve stenosis underwent aortic valve replacement with a Freestyle bioprosthesis by means of the described modified subcoronary technique over a 15-month period. Fifty of them were followed up by means of echocardiography at discharge, 6 months, and 1 year. There were 19 men and 31 women, with a mean age of 76 +/- 7 years (range, 58-87 years). Valve size ranged from 21 to 27 mm. RESULTS: Patients with bicuspid aortic valves had a significantly larger angle between both coronary ostia than patients with tricuspid aortic valves (P =.0001). The peak and mean systolic gradients decreased significantly during the first postoperative year for each valve size (P 相似文献   

Clinical outcomes with the Hancock II bioprosthetic valve

Background

The Hancock II bioprosthetic valve, which was first introduced to clinical use in 1978, differs from its predecessor in several ways. This study was designed to evaluate the durability and outcomes with this valve in patients who had isolated aortic or mitral valve replacements.

Methods

From 1991 to 1999, 459 patients underwent aortic valve replacement and 138 patients underwent mitral valve replacement with the Hancock II bioprosthesis (Medtronic Inc, Minneapolis, MN). The mean age was 73.2 ± 0.4 and 72.6 ± 0.8 years in the aortic and mitral groups, respectively. Most patients were in New York Heart Association Class III or IV (50% aortic group and 69% mitral group) and concomitant coronary artery bypass was performed in 49.4% and 52.8% of patients, respectively. Patients were assessed annually and follow-up was up to 129 months in the aortic group and 100 months in the mitral group.

Results

At 8 years, actuarial survival was 52% ± 5% in the aortic group and 57% ± 8% in the mitral group. Furthermore, the actuarial freedom from structural failure necessitating reoperation was 99% ± 0.5% in the aortic group and 98% ± 2% in the mitral group, and the actuarial freedom from repeat valve surgery due to all causes was 97% ± 2% and 96% ± 2%, respectively. Actuarial freedom from thromboembolic events was 89% ± 2% in the aortic group and 90% ± 5% in the mitral group.

Conclusions

The Hancock II valve has excellent midterm durability and clinical performance in older patients.     

An eight-year experience with porcine bioprosthetic cardiac valves

A total of 589 porcine bioprostheses were implanted in 509 patients from January, 1976, through December, 1983. Of the valves implanted, 390 were Hancock and 199 were Carpentier-Edwards. A total of 1,633 patient-years was accrued, with a mean follow-up of 38 months per patient. Two hundred eight patients had aortic valve replacement, 209 had mitral valve replacement, and 79 had multiple valve replacements, of which 46 were aortic and mitral replacements. The mortality for isolated aortic valve replacement was 5.8%; for isolated mitral replacement, 8.6%, and for all patients, 10.9%. Late mortality was 3.9% per patient-year. The actuarial survival rate at 5 years was 79% for aortic, 68% for mitral, and 76% for aortic-mitral valve replacement. There were 12 thromboembolic events (0.73% per patient-year). Two episodes occurred in patients with an aortic bioprosthesis, nine in patients with a porcine mitral valve, and one in a patient with mitral and tricuspid bioprosthetic valves. The probability of remaining free of thromboembolism at 5 years was 99% for the group having aortic valve replacement, 93% for those having mitral replacement, and 100% for the group having aortic-mitral valve replacements. Thirteen episodes of endocarditis occurred (0.8% per patient-year). Seven of the 13 patients died as a direct result of endocarditis. The probability of remaining free of prosthetic endocarditis at 5 years was 97% for the aortic valve replacement group, 95% for the mitral group, and 97% for the aortic-mitral group. There were 20 instances of xenograft failure (1.2% per patient-year). The probability of remaining free of valve failure at 5 years was 96% for the aortic valve replacement group, 93% for the mitral group, and 93% for the aortic-mitral replacement group. Primary tissue failure of a prosthesis occurred in seven patients, all with Hancock valves (0.43% per patient-year). As yet there has been no primary tissue failure of the Carpentier-Edwards prosthesis. There also appears to be a lower incidence of thromboembolism (Edwards, 0.3% per patient-year; Hancock, 0.8% per patient-year) and endocarditis (Edwards, 0.6% per patient-year; Hancock, 1.0% per patient-year). The low incidence of complications with the porcine bioprosthetic valve, especially the Carpentier-Edwards, encourages us to recommend its continued use, especially in situations in which anticoagulation is contraindicated.     

重症心脏瓣膜病的外科治疗

目的总结重症心脏瓣膜病的外科治疗结果,探讨提高早期生存率的措施。方法自2000年6月至2005年7月,对78例重症心脏瓣膜病患者施行瓣膜替换术。其中单纯二尖瓣置换12例,二尖瓣置换 三尖瓣成形22例,单纯主动脉瓣置换8例,二尖瓣 主动脉瓣置换 三尖瓣成形35例,二尖瓣置换 冠状动脉旁路移植术1例。结果死亡6例,其中术后并发低心排血量5例,心室颤动治疗无效死亡1例,死亡率7.69%。随访53例,平均随访2.5年,死亡5例。结论对重症心脏瓣膜病患者,注重改善术前心功能,掌握手术时机,尽量保留瓣下组织,选择合适瓣膜,重视围手术期处理,可提高手术成功率。     

Primary failure of pericardial valvular heterografts

From July 1981 to October 1984, 79 Hancock pericardial valves were implanted in 74 patients surviving the hospital period and with a mean age of 64.2 years. Fifty-two patients underwent aortic valve replacement, 16 had mitral valve replacement, 5 bad a double replacement and 19 associated procedures were performed. The mean survival is 48 months. Until 1st June 1987, 11 primary failures have required reoperation (14.9%), 4 in the mitral position (4.6% patient-years), 7 in the aortic position (3.01% patient-years). The time to reoperation was 48.4 months for the aortic orifice and 36.5 months for the mitral orifice. The lesions most frequently encountered were tears (7 cases), calcifications (5 cases) and stretching of valvular tissue (2 cases); two patients died during the postoperative phase of this operation. Despite the small number of patients followed, this series demonstrates of high incidence of dysfunction due to primary tissue degeneration as, after the 5th year, the actuarial rate of absence of primary lesion is 85.3 +/- 8% with no significant difference between the aortic and the mitral orifices, although dysfunction appears to occur more rapidly in mitral prostheses. These results are much less favourable than those obtained with Ionescu bioprostheses in the aortic position of those obtained with porcine bioprostheses in either position. This justifies very regular clinical and echocardiographic follow-up of patients with Hancock pericardial valvular heterografts.